Pasta Formulations, Portion Sizes and Their Effect on Appetite
SET
Understanding Pasta Formulations and Portion Size on Satiety in Healthy Weight Women
1 other identifier
interventional
24
1 country
1
Brief Summary
Investigators are interested in learning how appetite responds to pasta containing different amounts of protein and fiber when provided in two different portion sizes. In this research study, subjects will be asked to eat an entire pasta serving containing different amounts of protein and fiber mixtures. Subjects will be asked to do this on six separate occasions. One time subjects will not receive pasta, only water. After the pasta serving, there will be a buffet of deli style lunch items and subjects may eat as much they desire. Thereafter subjects will describe their feelings of hunger, fullness and desire to eat for 3 hours. In addition, blood will be taken throughout the study period to determine how eating pasta servings in different portion sizes impacts certain hormones released from the intestine, and therefore how they influence appetite. All study visits will take approximately 4 ½ - 5 hours.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Sep 2010
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2010
CompletedFirst Posted
Study publicly available on registry
September 13, 2010
CompletedStudy Start
First participant enrolled
September 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2011
CompletedJuly 27, 2021
July 1, 2021
1.2 years
September 9, 2010
July 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To investigate the effect of pasta formulations and portion size incorporated into a lunch meal on satiety (inhibition of further eating) as determined by subsequent second meal intake along with subjective responses on visual analog scales
Meals will be provided 4 1/2 hours after a standardized breakfast and subjects must eat the entire pasta serving. After the pasta serving, a buffet lunch will be served and subjects may eat as much as desired. Immediately thereafter, subjects will record satiety responses at 0 min (immediately post consumption), 20, 40, 60, 90, 120, 150 and 180 on a visual analog scale (VAS). The subject will answer a series of questions on the VAS at each respective time point describing their feelings of hunger, fullness and desire to eat.
3 hour post prandial study
Secondary Outcomes (1)
To investigate the effect of pasta formulations and portion size incorporated into a lunch meal on postprandial intestinal phase mechanisms of satiety and meal-associated metabolic response patterns
3 hour postprandial study
Study Arms (7)
experimental pasta B, small
EXPERIMENTALsmall portion experimental pasta B
experimental pasta C, small portion
EXPERIMENTALsmall portion experimental pasta C
Control pasta, small
PLACEBO COMPARATORsmall portion Control pasta
No Load
OTHEROnly water
Control pasta, medium
ACTIVE COMPARATORmedium portion Control pasta
experimental pasta B, medium portion
EXPERIMENTALmedium portion experimental pasta B
experimental pasta C, medium portion
EXPERIMENTALmedium portion experimental pasta B
Interventions
experimental pasta C, small portion
experimental pasta B, medium portion
experimental pasta C, medium portion
Eligibility Criteria
You may qualify if:
- Females
- years of age and older
- Body mass index (BMI) between 18.5 and 24.9 kg/m2, inclusive
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- Unrestrained eater (score \< 10 on the Three Factor Eating Questionnaire)
You may not qualify if:
- Pregnant and/or lactating or planning for pregnancy
- Allergies or intolerances to foods consumed in the study
- Fasting blood glucose \> 110 mg/dL. Subjects identified with elevated fasting blood glucose levels will be will be advised to contact their primary care physician for appropriate follow-up care.
- Taking over the counter fiber supplements or other supplements that may interfere with the study procedures or endpoints
- Taking prescription medications that may interfere with study procedures or endpoints ( medications that affect appetite)
- Subjects with unusual dietary habits (e.g. pica)
- Actively losing weight or trying to lose weight (unstable body weight fluctuations of \> 5 kg in a 60 day period)
- Excessive exercisers or trained athletes
- Addicted to drugs and/or alcohol
- Medically documented psychiatric or neurological disturbances
- Smoker (past smoker may be allowed if cessation is \> 2 years)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Nutrition Research Center
Chicago, Illinois, 60616, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Britt Burton-Freeman, PhD, MS
Clinical Nutrition Research Center, Illinois Institute of Technology
- PRINCIPAL INVESTIGATOR
Indika Edirisinghe, PhD
Clinical Nutrition Research Center, Illinois Institute of Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2010
First Posted
September 13, 2010
Study Start
September 15, 2010
Primary Completion
November 18, 2011
Study Completion
November 18, 2011
Last Updated
July 27, 2021
Record last verified: 2021-07